小儿清肺分散片中黄芩苷溶出度测定方法

Method for determination of Baicalin solubility of Xiaoer Qingfei Dispersible Tablet

目的建立小儿清肺分散片中黄芩苷的溶出度测定方法。方法采用HPLC法,建立黄芩苷的含量测定方法;采用单因素试验法,以同一时间点的溶出度为指标,分别考察了溶出介质、溶出方式及转速对黄芩苷溶出的影响。结果黄芩苷浓度在0.025~0.125 mg/m L范围内与峰面积呈良好的线性关系（r=0.999 9）,平均回收率为100.41%（n=9）,RSD=2.98%;小儿清肺分散片的溶出条件为采用桨法,以p H值为6.8磷酸盐缓冲液为溶出介质,转速为75 r/min,取样时间为40 min。结论本方法操作简便,结果准确,重复性好,可作为小儿清肺分散片的溶出度测定方法。

Objective To establish the method for determination of Baicalin solubility of Xiaoer Qingfei Dispersible Tablet. Methods HPLC methed was used to determine the content of baicalin; By single factor experiment, at the same time with the solubility as index, investigating the stripping medium, stripping method, stripping speed respectively that effect of baiealin stripping. Results Baicalin was linear in the range of 0. 025 - 0. 125 mg/mL（ r = 0. 999 9）, and the average recovery was 100.41% （n = 9） with RSD = 2.98% ;The digestion conditions of Xiaoer Qingfei Dispersible Tablet is using the paddle, with pH 6.8 artificial intestinal solution, stripping speed 75 r/min, the sampling time is 40 min. Conclusion This method is accurate, reliable, specific and reproducible, and can be used for the stripping method of Xiaoer Qingfei Dispersible Tablets.